BASKING RIDGE, N.J. -- (BUSINESS WIRE) -- Ipsen Biopharmaceuticals, Inc., the U.S. affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), today announced that a supply of Increlex® (mecasermin [rDNA origin] injection) will be available in the U.S. starting June 2, 2014. In collaboration with the U.S. Food and Drug Administration (FDA), Ipsen is releasing one batch of Increlex’s active ingredient. Ipsen anticipates that additional lots will be released in the coming months, as the company continues to work closely with the FDA to make additional Increlex lots available as soon as possible.
Increlex is used to treat children with a form of growth failure called severe primary IGF-1 deficiency (IGFD), which can cause permanent short stature. The supply interruption of Increlex occurred in mid-June 2013.
“We are very pleased that the resupply of Increlex will be taking place in the U.S., as we have been working in very close collaboration with the FDA and the manufacturer, Lonza, to make this happen,” said Marc De Garidel, Chairman and Chief Executive Officer of Ipsen. He added: “While the manufacturing of a product like Increlex remains challenging, Ipsen is committed to the children across the world who need this treatment.”
The active substance in Increlex® is a recombinant insulin-like growth factor of human origin (IGF-1). IGF-1 is the direct hormonal mediator of stature and bone growth and must be present for normal growth of bones and cartilage in children. In severe primary IGF-1 deficiency, children’s serum IGF-1 levels are low despite the presence of normal or elevated growth hormone (GH) levels. If the IGF-1 is not present in sufficient quantities, the child will not reach a normal stature.
Ipsen markets the orphan drug, which is considered to be a drug of medical necessity, in the United States and most European countries. On April 25, 2013, Ipsen announced that the supplier of Increlex’s active ingredient, Lonza Biologics Inc., was facing manufacturing issues with Increlex at its Hopkinton, MA site. Lonza has been working closely with the U.S. Food and Drug Administration (FDA) to address these issues. The supply interruption occurred in mid-June 2013 in the U.S. and in Q3 2013 in Europe and the rest of the world. Resupply in the EU and other markets has been effective since December 2013.
Increlex is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (IGFD), or with growth hormone (GH) gene deletion, who have developed neutralizing antibodies to GH. Severe primary IGFD is defined by height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated growth hormone (GH).
Increlex is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating Increlex treatment. Increlex is not a substitute to GH for approved GH indications. Increlex has not been studied in children < 2 years of age.
Important Safety Information
Warnings and Precautions:
Common adverse reactions include: hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy.
Please see the full Prescribing Information for Increlex available at http://increlex.com/pdf/hcp-full-prescribing-information.pdf
Patient Information for Increlex available at http://increlex.com/pdf/patient-full-prescribing-information.pdf
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2013. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by 3 franchises: neurology, endocrinology and uro-oncology. Moreover, the Group has an active policy of partnerships. Ipsen's R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2013, R&D expenditure totaled close to €260 million, representing more than 21% of Group sales. Moreover, Ipsen also has a significant presence in primary care. The Group has close to 4,600 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information, visit www.ipsen.com.
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